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A Strong FDA

A Strong FDA is one of five initiatives established for FDA to address five critical challenges facing the agency.

Through this initiative, FDA will maintain a strong science-based organization to support its risk management responsibilities by: attracting and retaining the most talented scientists; operating a streamlined and cost-effective agency that is optimally organized to support mission-critical activities; and implementing the President's Management Agenda to deliver value to our constituents.

The following is an excerpt describing this initiative from FDA's FY 2004 Annual Performance Plan.

Problem
Desired Outcome
Key Strategies
FY 2004 Goal Highlights
Current Status
FY 2002 Performance Goals
FY 2001-2002 Highlights


Related Information

Problem

In addition to the terrorist threat, other major environmental forces are exerting a major influence on how FDA must operate: globalization of trade and regulation, increasing industry use of the Internet and continuing innovations in science and technology.

These forces for change coincide with the direction of the Administration's leadership through the President's Management Agenda. Following this agenda, the Agency seeks to achieve excellence in management practices by becoming more streamlined, cost-effective, oriented toward strategic alliances, Internet-based and citizen-centered.

Desired Outcome

• Ensure that state-of-the-art scientists and health professionals are recruited and retained so that the American people can benefit from scientifically sound risk management decisions.
• Operate a streamlined Agency that is optimally organized to support mission-critical activities.
• Maximize cost-effective performance of functions by achieving a rational balance of in-house and outsourced activities.
• Enhance capacity to produce program performance data and management control systems that allow the Agency to maximize performance relative to targeted public health outcomes.
• Maintain FDA's high standards as a citizen-centered Agency accountable for results.

Key Strategies

Each of the strategies outlined below are aligned with the President's Management Agenda to make all Federal government agencies more streamlined and citizen-centered.

Recruit, Reward and Retain State-of-the-art Scientists and Health Professionals - FDA will continue to aggressively recruit the highest caliber professionals and utilize web-based recruiting strategies to broaden reach and accelerate access. Both monetary and non-monetary incentives are critical in rewarding the top performers in FDA's workforce. The Agency must also assure that scientists maintain state-of-the-art expertise by training them in emerging technologies. Without understanding the science underpinning new products we cannot make credible regulatory decisions.

Improve Management Systems - FDA continues to focus on achieving excellence in management practices by improving the effectiveness of a wide range of systems that support Agency decisions. These include financial management (including travel and procurement), information management, and security. The Agency has embarked on several initiatives that include implementing a new financial management system, upgrading the current Legacy systems, accelerating movement toward electronic procurements, integrating Agency information systems, and establishing a "continuity-of-operations" plan in the event of an emergency.

Design Effective Organizational Structures - The objective of a well-designed organization structure should be to support the mission of the organization. In FDA's case, several efforts are underway to improve organizational alignments. In response to the OMB Directive of May 8, 2001, FDA submitted a restructuring plan, based on a workforce analysis, to make the Agency more streamlined and "citizen-centered." The Agency has also awarded a contract to determine the most effective configuration of administrative functions, and will be implementing contractor recommendations during FY 2003.

Achieve Cost-effective Performance of Traditional Government Activities - FDA has committed to examining its commercial FTEs to determine which activities would be more cost-effective to implement if outsourced. The aim is to arrive at a rational balance of in-house and outsourced activities that will maximize the overall cost-effectiveness of Agency resources.

Focus on Performance and Accountability In 1997, Congress enacted the FDA Modernization Act, which reaffirmed the Agency's long tradition of collaboration with our constituents. Section 406(b) of the Modernization Act directed the Agency to consult with our constituencies to ensure that we fulfill our statutory mandates and we communicate clearly with our stakeholders. The President's Management Agenda reinforces the importance of being a citizen-centered government; strive for long term outcome goals that meet citizens' needs; and identify the resources necessary to achieve those goals through effectively integrating performance and budgetary planning.

FDA strategies are aligned with the President's Management Agenda. Agency leadership is committed to the establishment of long-term outcome goals that make a difference to the U.S. taxpayer. To this end, we are developing the capacity to produce program data to better monitor, measure and manage Agency activities and resources to maximize performance relative to targeted public health outcomes. We will also strive for closer integration of performance and budget by establishing systems that will provide the necessary information to identify the performance-resource linkage. Finally, a system of performance contracts will be implemented to establish the linkage between individual and organizational accountability for performance results.

Demonstrate enhanced capacities of FDA website for providing information to industry on FDA-enforced regulations - FDA recognizes the need for innovative methods to communicate important public health information to the public. FDA is currently creating and implementing effective communication methods to give consumers the information they need to make better health decisions. One improvement is enhancing the FDA website. FDA is continuing to increase the percentage of applications submitted electronically and enhanced electronic capacities for domestic food inspections and imports.

Performance Goal Highlights for FY 2004

• Reduce the number of review levels in the Agency to help streamline operations.
• Increase the percentage of commercial FTEs that will be reviewed for outsourcing.
• Expand the use of Agency-wide Enterprise IT architecture in accordance with the Department of Health and Human Services Plan.
• Complete system preparation to implement Financial Enterprise Solutions, FDA's version of UFMS.

Current Status

Human Capital - FDA is faced with the challenge of replacing its critical knowledge base as a large segment of its workforce reaches retirement age. Because federal salaries cannot match industry salaries, FDA needs greater flexibility in recruitment strategies and in pay incentives. Using initiatives such as Quick Hire, over 800 Investigators and Analysts are on board to increase surveillance of products at the border. FDA has used appointment mechanisms in the excepted service, i.e., Title 42 of the Public Health Service Act. However, special hiring authorities are not appropriate for all hiring situations.

Congress funded pay increases in FY 2002. The provision of pay increases as part of the FY 2003 budget request to Congress will go a long way toward re-establishing equity among both managers and employees.

FDA has initiated non-monetary, quality of work life incentives that maintain a highly motivated workforce. In recent federal employee surveys FDA respondents gave the Agency a 72 percent favorable rating in employee job satisfaction - highest of the 49 agencies surveyed.

FDA has also aligned its workforce planning efforts with the Department's Strategic Workforce Plan. This initiative will enhance FDA ability to recruit and retain a diverse workforce; implement strategies that allow for replacement of our aging workforce; and attract high quality professional employees needed for the Agency to address the complex challenges it will face in the future.

Management Systems - FDA is initiating the first steps in implementing a Financial Enterprise Solutions System that will be aligned with the HHS Unified Financial Management System. This will provide qualitative and quantitative benefits to FDA because it will achieve improved business processes and provide more accurate and timely information to better support FDA's and DHHS' mission.

In the area of information technology (IT), FDA will establish an Agency-wide enterprise architecture. Top priorities focus on Counterterrorism and establishing an Agency-wide registration system for all regulated establishments and their products. PDUFA III information demands will also be greatly facilitated by enterprise IT architecture supporting that arena of decisions.

Major IT challenges remain, including Cyber security. FDA is meeting this challenge by assessing the security readiness of all of its major IT system components. In FY 2003, FDA is expected to assess 100 percent of the IT infrastructure and one third of the major systems for compliance with provisions of the Government Information Security Reform Act (GISRA) and perform any needed corrections.

Organization structure - FDA is in the process of streamlining its organizational structure by: flattening the hierarchy; consolidating administrative functions and locations; and implementing a customer-responsive "shared services" system.

Flatten the hierarchy - FDA is striving to reduce the number of review levels for decision making within the Agency to no greater than four, which is consistent with the President's Management Agenda and Departmental guidelines. Reducing review levels will allow for a more effective structure and a streamlined organization, as well as increase the span of control for managers across the Agency.

Consolidation - FDA is consolidating administrative functions across the Agency, and continues to implement its plan to consolidate headquarters facilities with the aim of improving the cost effectiveness of headquarters operations. Facilities that are now scattered among many locations will be concentrated in two locations in White Oak and College Park, Maryland. Currently, FDA Headquarters is located in 40 buildings in 18 locations. As a part of the FDA Revitalization Act, FDA has embarked on a five-year plan to relocate the major portion of its headquarters personnel to White Oak, Maryland. This project, coupled with ongoing efforts to reduce supervisory ratios and delayer headquarters staff will afford FDA maximum flexibility to move resources closer to the day-to-day "front line" programmatic work of the Agency.

Shared Services - During FY 2003 FDA will develop detailed plans for the shared services organization, following completion of the contract for analysis of FDA's administrative services. In FY 2004, FDA will begin the actual implementation of the shared service organization. This will be a customer-focused organization in which business units establish service priorities and services which will be tailored to meet the individual needs of the business units (programs). Service level agreements will be drawn between administrative service providers and the customers.

The shared service organization will be governed by a group which will include representatives of both providers and customers. Performance will be monitored against 'best practices' in internal and external organizations. The shared services model will help FDA focus on its 'core business'; create satisfied customers and employees; leverage technology and information; and more effectively manage costs.

Change Management - Because many of the management improvement initiatives represent major Agency-wide efforts, and are occurring simultaneously, they have the potential to significantly impact the work life of many employees. In order to make the conversion as smooth and as productive as possible, a Change Management Integration Team of FDA senior personnel has been established. The purpose of this team is to assist the Agency in managing the communication, information sharing, data gathering, and implementation associated with each of the management improvement initiatives.

FY 2002 Performance Goals

Highlights of FY 2001-2002 Accomplishments

• FDA finalized and published its Strategic Workforce Plan and provided it to all employees via the Internet. Key strategies addressed: recruitment and retention; workforce leveraging; workforce skills; scientific workforce development; and, leadership development.
• FDA and GSA have begun construction of CDER laboratories at the White Oak facility, which will result in approximately 114,000 square feet of laboratory, animal holding, and office space that will be occupied by approximately 200 CDER employees by September 2003.
• FDA's Website has received a Bronze Award in the "Health Promotion/Disease & Injury Prevention Information" category of the latest WWW Health Awards competition. This twice-yearly contest is sponsored by the Health Information Resource Center, which holds the competition to provide "a seal of quality for electronic health information." A panel of health experts judges entries for content, format and overall quality.
• FDA has begun streamlining the structure of the Agency. Efforts are underway to reduce the number of reporting layers to no more than four and initial steps have been taken to consolidate selected functions - in particular human resources and information technology.
• FDA initiated performance-based contracts for all senior executives. These contracts were used to align individual leadership commitments with key Departmental and Agency Performance Goals. The contracts were also used to evaluate end-of-year performance, and make appropriate adjustments for FY 2003.

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